Unboosted Atazanavir as Initial ART Therapy in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01459575

Recruitment Status
:
Completed

First Posted
: October 25, 2011

Last Update Posted
: October 25, 2011

Sponsor:

National Center for AIDS/STD Control and Prevention, China CDC

Collaborator:

BMS company

Information provided by (Responsible Party):

NCAIDS, National Center for AIDS/STD Control and Prevention, China CDC

This is an open-label, Pilot study.The study hypothesis is that the feasibility and efficacy of a non-boosted ATV based HAART will be well as the first line treatment in a Chinese resource-limited setting.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Both females of child-bearing potential and males must utilize effective barrier contraception - other contraception in addition to barrier methods are permitted

Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

Patients who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.

Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.

History of hemophilia

Proven or suspected acute hepatitis in the 30 days prior to study entry. Subjects with chronic hepatitis are eligible provided that their liver function enzymes are < 3 times the upper limit of normal.

Presence of cardiomyopathy.

A history of arrhythmia or clinical symptoms potentially related to heart block or second / third degree heart block.

Inability to tolerate oral medication

Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.